DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/9/2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 6, 8-10, 12-15 and 17-20, in the reply filed on 7/9/2024 is acknowledged.
Response to Arguments
All of Applicant’s arguments filed 10/9/2025 have been fully considered.
In view of the amendments to the claims the 112(b) rejections presented in the office action mailed 4/10/2025 are withdrawn. Applicant’s arguments regarding these rejections are moot.
Claim Rejections - 35 USC § 103
Applicant argues that the nature of the compositions of the Marteinsson and their use are different that those presented by the instant claim. The claimed thin membrane of claim 1 isn’t taught by Marteinsson.
This is not persuasive, while the film as claimed and Marteinsson might be described differently, they have the same structure and therefore are expected to function in the same manner.
Applicant argues that Stone does not provide any information regarding a composition comprising chitosan and how to use this to promote the growth of microbiota and in the event a skilled artisan would consider the teachings of Stone sizes of 100µm and 50µm, thus not teaching thin films of .001nm to 10µm as claimed.
This is not persuasive, while Stones doesn’t teach the liquid cosmetic as claimed, this is made obvious by Marteinsson as the rejection is based on a combination of references. Regarding the film thickness as taught by Stone, while Stone specifically mentions the sizes 100µm and 50µm, Marteinsson teaches “less than about 50 µm” as such amounts of less than 50 µm are contemplated and provides a range that overlaps with the claimed invention and overlapping ranges are prima facie obvious absent evidence of criticality.
Applicant argues that the claims as amended require the composition to promote growth a beneficial microbiota and Ex. 3 of the specification shows that low acetylated chitosan is capable of this.
This is not persuasive as Marteinsson teaches formulating the composition to comprise Chitosan having a degree of acetylation of 0-10% and teaches that these formulations can be used to treat skin conditions and which promotes natural microbiota of skin and reduce undesirable microorganisms. While Marteinsson doesn’t specific promoting growth, the prior art makes obvious the claimed composition and the performance of the claimed method steps, as such therefore the composition claimed and the composition of the prior art are expected to have the same properties, absent evidence to the contrary. Applicant reliance on Ex. 3 only shows what the claimed composition of capable of, there is no evidenced of unexpected results presented.
Applicant argues that examples 1-2 of Marteinsson do not have a chitosan with the degree of acetylation as claimed and which differentially promotes the growth of microbiota as claimed. While Fig 2 of Marteinsson shows the inhibition of 2 pathogenic strains, it does not show the promotion of beneficial microorganisms and does not indicate what degree of acetylation was used.
This is not persuasive as the teaching of Marteinsson are not limited to the working examples. Marteinsson teaches formulating the composition to comprise Chitosan having a degree of acetylation of 0-10% and teaches that these formulations can be used to treat skin conditions and which promote natural microbiota of skin and reduce undesirable microorganisms, thus Marteinsson makes obvious the claimed method and as the prior art makes obvious the claimed composition and the performance of the claimed method steps, the composition claimed and the composition of the prior art are expected to have the same properties, absent evidence to the contrary.
New Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, the phrases "(w/w)" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Maintained/Modified Claim Rejection - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6, 8-10, 12-15, 17-19, 26 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marteinsson (WO 2018/130951) and Stone (US 2006/0210511), as evidenced by Olbertz (WO 2006/108540).
Marteinsson discloses chitosan containing formulations which are aqueous and either liquid or viscous-like, varying in concentration and type of chitosan and acid used. These can be used for topical application (Abs).
Marteinsson teaches the chitosan to be applied in the form of a solution (i.e. a liquid) to treat a skin condition which promotes natural microbiota of skin (reading on ectodermal tissue) and reduce undesirable microorganisms and results in a smooth and tailor made bandage-like film that will be degraded by skin enzymes, reading on cosmetic membrane of instant claim 2 [0073] and reads on promoting the growth of one or more beneficial…taxa.” While Marteinsson doesn’t specific promoting growth, the prior art makes obvious the claimed composition and the performance of the claimed method steps, as such therefore the composition claimed and the composition of the prior art are expected to have the same properties, absent evidence to the contrary.
Regarding claim 1 and 8: Marteinsson teaches the chitosan to have a percentage of deacetylation of about 90-100% (i.e. 0-10% acetylation) ([0075] and Marteinsson - claim 35) which overlaps with the claimed less than 5% of acetylation and overlapping ranges are prima facie obvious absent evidence of criticality.
Marteinsson teaches that the composition can be for cosmetic and/or personal care use (Marteinsson – claim 27).
Marteinsson teaches that the chitosan-containing composition formulations can be used to cover and protect as a film-forming ingredient [0064].
Regarding claim 6: Fig. 2 of Marteinsson discloses the antibacterial activity of 0.65% (w/w) of chitosan lactate solution against two skin pathogens, Pseudomonas aeruginosas and Staphylococcus aureus. As the prior art makes obvious the claimed composition and the performance of the claimed method steps, the composition claimed and the composition of the prior art are expected to have the same properties, absent evidence to the contrary.
Regarding claims 9-10: Marteinsson teaches that an organic acid such as lactic acid or glycolic acid can be added to solubilize the chitosan and comprises from 40-100% of the weight of the chitosan [0037-0038]. Marteinsson teaches that mixtures of two or more of these acids can be used therefore it would have been prima facie obvious to use a mixture of lactic acid and glycolic acid with a reasonable expectation of success.
Regarding claim 12: Marteinsson teaches the chitosan to be use in amounts of 1-3% and teaches the acid to be used in amounts of 40-100% of the chitosan, therefore the acid(s) can be used in amounts ranging from 0.4-3% based in the weight of the composition which overlaps with the claimed ranges.
Regarding claims 13-14: Marteinsson teaches that preservatives such as benzyl alcohol can be used [0084], reading on disinfectant.
Regarding claims 15 and 28: Marteinsson teaches the composition to be applied to skin topically and to the skin surface, which reads on epidermis [0073 and 0087].
Regarding claims 17 and 18: Marteinsson teaches application of the composition to skin with irritated skin and/or sunburn [0073].
Regarding claim 19: Marteinsson teaches treating a skin condition such as inflammation due to bedsore, as evidenced by Olbertz bedsore are caused by lying for a long time (pg. 2, paragraph 1).
Marteinsson does not teach the formed membrane to have a thickness ranging from 0.001nm to 50µm, 0.001nm to 10µm or 0.001nm to 1 µm as recited by instant claims 1 and 26.
Stone teaches methods of treating skin by using a chitosan polymer to form a smooth and continuous film on the skin [0055]. Stone teaches that the film is formed by applying compositions on the skin and are less than, on average, about 100 microns in thickness, such as less than about 50 microns [0029], this overlaps with the amounts recited by instant claims 3 and 25-26. Stone teaches that applying too much it results in the deposition of a film that is too thick and flaking or cracking of the film on the skin results [0108].
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Marteinsson with those of Stone and apply the composition of Marteinsson in amounts that allow a film having a thickness of less than about 50 microns to form as this is taught to be a suitable thickness for treating skin conditions using chitosan and its prima facie obvious for a skilled artisan to pursue the known options within his or her own technical grasp to achieve the predictable result of forming a film on the skin. One of skill in the art would have also been motivated to optimize the thickness of the film to avoid a film that is too thick and flakes or cracks on the skin.
Claim(s) 1, 6, 8-10, 12-15, 17-19, 20, 26 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marteinsson (WO 2018/130951) and Stone (US 2006/0210511), as applied to claims 1, 6, 8-10, 12-15, 17-19, 26 and 28 above, and further in view of Almond (US 6,016,915), as evidenced by Olbertz (WO 2006/108540).
As discussed above, Marteinsson makes obvious the limitations of claims 1, 6, 8-10, 12-15, 17-19, 26 and 28, however, Marteinsson does not teach composition to be applied to skin which has been previously disinfected.
Marteinsson teaches that the composition can be used to clean wounds and teaches a method wherein a basic wound cleaning treatment with a dedicated agent was first performed and then chitosan formulation was applied [0095].
Almond teaches that for cleaning minor wounds an antiseptic wipe (i.e. disinfectant) can be used (Abs).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Marteinsson with those of Almond. A skilled artisan would have been motivated to use the antiseptic wipe to clean the wound or skin surface prior art applying the chitosan composition as Almond teaches that wounds are typically cleaned by using an antiseptic and Marteinsson teaches treating the skin area with a wound cleaner prior to chitosan treatment.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613